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Sandoz receives eighth European Commission approval for a biosimilar with Ziextenzo® (pegfilgrastim)

On November 27, 2018 Sandoz, a Novartis division and the pioneer and global leader in biosimilars, reported that the European Commission (EC) granted marketing authorization for biosimilar Ziextenzo (pegfilgrastim) (Press release, Novartis, NOV 27, 2018, View Source [SID1234531635]).

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Ziextenzo is indicated to reduce the duration of neutropenia and incidence of febrile neutropenia in adult patients treated with cytotoxic (anti-cancer) chemotherapy for malignancy with the exception of chronic myeloid leukemia and myelodysplastic syndromes.[1] These indications match those of the reference medicine.**[1],[3]

"Despite advancements in cancer treatment, febrile neutropenia remains one of the most significant complications of chemotherapy and is a major cause of morbidity,"[4] said Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz. "With the approval of Ziextenzo, a long-acting version of oncology supportive medicine filgrastim, we look forward to providing a treatment option that delivers the possibility of further reducing both the personal and financial burden of cancer."

This approval was based on comprehensive analytical, preclinical and clinical data. In these studies, Ziextenzo matched the reference medicine in terms of safety, efficacy and quality.[5]-[8] Pegfilgrastim, the active substance in Ziextenzo, is a long-acting form of filgrastim, which stimulates the production of white blood cells.[1]

"Pegfilgrastim biosimilars, such as Ziextenzo, mark a true advancement for people with cancer. These medicines help deliver optimized long-acting dosing and patient convenience while creating savings for our hard-pressed health systems," said Dr. Paul Cornes, oncologist and member of the Continuing Medical Education program of the European Association of Hospital Pharmacists and Core Lecturer for the European School of Oncology, United Kingdom.

Sandoz remains committed to making access happen for patients and leads in biosimilars with eight approved biosimilars worldwide, including five in the last 18 months. We look forward to making available a robust portfolio of biosimilar medicines that enables early and expanded access for patients as well as generates healthcare savings worldwide.

About Ziextenzo (pegfilgrastim)
Pegfilgrastim is a long-acting form of filgrastim. Filgrastim is very similar to a natural protein (granulocyte-colony stimulating factor) – also known as G-CSF – produced by a person’s own body. Filgrastim may be used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever). Febrile neutropenia is caused by cytotoxic chemotherapy (medicines that destroy rapidly growing cells); white blood cells are important as they help your body fight infection.[1]

The Center for Cell and Gene Therapy at Baylor College of Medicine to Present at the 60th American Society of Hematology Annual Meeting

On November 27, 2018 Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company, today reported that data from three abstracts—including an oral presentation—were accepted for presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH 2018) (Press release, TapImmune, NOV 27, 2018, View Source [SID1234531632]). The studies describe results achieved using multi-tumor antigen specific T cells that were developed at the Baylor College of Medicine in the laboratories of Dr. Ann Leen and Dr. Juan Vera, and exclusively licensed to Marker.

Among the highlights, results from an ongoing Phase 1 study in patients with multiple myeloma will be reviewed in an oral presentation by Premal Lulla, M.B.B.S., Assistant Professor of Medicine at the Center for Cell and Gene Therapy, Hematology-Oncology, at the Baylor College of Medicine.

ASH 2018 will take place in San Diego, CA from December 1-4.

Oral Presentation Details:

Title: Safety and Efficacy of Multiantigen-Targeted T Cells for Multiple Myeloma (Abstract # 1014)

Date: Monday, December 3, 2018

Time: 7:30 p.m. PST (San Diego Convention Center, Ballroom 20D)

Poster Presentation Details:

Title: Targeting Lymphomas Using Non-Engineered, Multi-Antigen Specific T Cells (Abstract #1685)

Date: Saturday, December 1, 2018

Presentation Time: 6:15 p.m. – 8:15 p.m. PST (San Diego Convention Center, Hall GH)

Title: Adoptive T-Cell Therapy for Acute Lymphoblastic Leukemia Targeting Multiple Tumor Associated Antigens (Abstract #2693)

Date: Sunday, December 2, 2018

Presentation Time: 6:00 p.m. – 8:00 p.m. PST (San Diego Convention Center, Hall GH)

DNAtrix’s Oncolytic Virus Expressing OX40 Ligand Treats First Patient in Recurrent Glioblastoma Clinical Trial

On November 26, 2018 DNAtrix, a leader in oncolytic virus immunotherapies for cancer, reported the treatment of the first patient with DNX-2440, an oncolytic virus expressing OX40 ligand (OX40L) (Press release, DNAtrix, NOV 26, 2018, View Source [SID1234534217]). The first-in-human Phase 1 study is evaluating the safety and efficacy of DNX-2440, administered by Alcyone’s Microtip Cannula at the time of biopsy, to patients with recurrent glioblastoma for whom surgery is not possible or planned. DNX-2440 is the second DNAtrix oncolytic adenovirus to advance into the clinic.

DNX-2440 is engineered from DNAtrix’s highly potent oncolytic adenovirus, DNX-2401 (tasadenoturev), which has already demonstrated the ability to selectively kill tumor cells and trigger a powerful immune response directed against the tumor in several clinical studies. In addition to these mechanisms, DNX-2440 expresses OX40L, a critical costimulatory molecule known to enhance antitumor immune responses.

Extensive preclinical data have shown that DNX-2440 elicits tumor-specific immune memory and an abscopal effect (shrinking of an untreated tumor distant from the treated tumor), leading to prolonged survival in difficult-to-treat animal models of cancer, including gliomas, melanomas, and breast and lung cancers.

"Based on our observations from past studies with DNX-2401, we expect DNX-2440 to be safely administered and well tolerated, and to enhance clinical responses and prolong survival in patients with this devastating disease," said Ricardo Diez Valle, MD, Principal Investigator of the study at Clínica Universidad de Navarra, in Spain.

"DNX-2440 should trigger an immune response directed to tumors that are otherwise refractory to single agent immunotherapies," said Frank Tufaro, PhD, CEO of DNAtrix. "We now have two unique products in development and are planning to evaluate DNX-2440 for other malignancies, reinforcing our commitment to developing oncolytic immunotherapies for difficult to treat tumors."

ABEONA THERAPEUTICS ANNOUNCES CEO TRANSITION

On November 26, 2018 Abeona Therapeutics Inc. (Nasdaq: ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, reported the immediate termination of its Chief Executive Officer, Dr. Carsten Thiel due to personal misconduct that violated the Company’s Code of Business Conduct and Ethics (Press release, Abeona Therapeutics, NOV 26, 2018, View Source [SID1234531740]). The Company has appointed its Head of Research & Development and Chief Medical Officer, Dr. João Siffert, as Interim Chief Executive Officer.

Dr. Thiel’s termination follows an investigation by independent members of the Company’s Board of Directors and external counsel into allegations of misconduct towards colleagues that the Board concluded violated the Company’s Code of Business Conduct and Ethics and was inconsistent with its expectations for Abeona’s CEO.

Dr. Thiel’s termination is not related to the condition of the Company’s finances, operations or clinical programs, nor due to any disagreement with the Company regarding its management of financial reporting, scientific data or other practices.

"We expect all employees, regardless of title or responsibility, to conduct themselves ethically and in accordance with company policies, and are committed to ensuring an environment of respect, integrity and ethical conduct at Abeona," said Steven H. Rouhandeh, Chairman of the Board and Executive Chairman. "The Board is confident that Abeona is in good hands while we search for a new CEO as João’s deep expertise in drug development and gene therapy will ensure that the company continues operating effectively without interruption."

Dr. Siffert has successfully led multiple drug development programs from pre-clinical to regulatory approvals in the U.S. and Europe, and has held several scientific leadership positions in biotech and pharma, including programs in gene therapy. In 2017, Dr. Siffert was appointed to the Board of Directors of gene therapy developer AveXis, which was subsequently acquired by Novartis. He served as Chief Medical Officer for Ceregene from 2007 to 2011, where he was responsible for clinical development of adeno-associated viral (AAV2)-based gene therapies for Parkinson’s and Alzheimer’s diseases. Dr. Siffert also led the R&D and medical organizations at Avanir Pharmaceuticals and Avera Pharmaceuticals before most recently guiding translational research, clinical development, regulatory, and medical affairs as Chief Scientific and Medical Officer for Nestle Health Science.

The Board has formed a search committee to identify a permanent successor, with the assistance of a leading executive search firm

Molecular Templates to Present at the Evercore ISI and BMO Healthcare Conferences

On November 26, 2018 Molecular Templates, Inc. (Nasdaq: MTEM), a clinical-stage oncology company focused on the discovery and development of the company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, reported that its management will provide a corporate update at the forthcoming Evercore ISI HealthCONx BioPharma, MedTools, and Devices Conference, and the BMO Capital Markets Prescriptions for Success Healthcare Conference (Press release, Molecular Templates, NOV 26, 2018, View Source [SID1234531657]).

Evercore ISI HealthCONx – BioPharma, MedTools, & Devices Conference
Date: Wednesday, November 28
Time: 7:35 am Eastern Time
Location: Boston Harbor Hotel
Webcast: View Source

BMO Capital Markets 2018 Prescriptions for Success Healthcare Conference
Date: Wednesday, December 12
Time: 9:00 am Eastern Time
Location: The Mandarin Oriental, New York